Methotrexate EP Impurity H CAS 67022-39-3
| CAS No. | 67022-39-3 |
| Molecular Formula | C21H24N8O5 |
| Molecular Weight | 468.47 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Methotrexate EP Impurity H (C21H24N8O5) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
As a process- or degradation-related impurity, Methotrexate EP Impurity H (CAS 67022-39-3, C21H24N8O5) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Physical & Chemical Properties
| Molecular Formula | C21H24N8O5 |
| Molecular Weight | 468.47 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >99.76% |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1976 |
| Nitrogen Atoms | 8 |
Related Methotrexate Standards
- Methotrexate EP Impurity I (CAS 66147-29-3)
- Methotrexate Impurity 28 (CAS 5939-37-7)
- Methotrexate-d3 (CAS 432545-63-6)
- Methotrexate Impurity 18 (CAS CATO-C4X-115418)
- Methotrexate Dimethylamide (CAS 71074-44-7)
- Methotrexate EP Impurity C (CAS 2410-93-7)
- Methotrexate impurity N3 (CAS 65148-64-3)
- Methotrexate EP Impurity J (CAS 34378-65-9)
Recommended Standards
- N-(5-((2-Oxo-2-((4-(trifluoromethyl)phenyl)amino)ethyl)thio)-1,3,4-thiadiazol-2-yl)-2-phenoxyacetamide (CAS 897757-87-8)
- N-(5-((2-Oxo-2-((3-(trifluoromethyl)phenyl)amino)ethyl)thio)-1,3,4-thiadiazol-2-yl)-2-phenoxyacetamide (CAS 897620-55-2)
- Fmoc-Gly-Gly-Gly-Gly-OH (CAS 1001202-16-9)
- Mubritinib (CAS 366017-09-6)
- Parecoxib Impurity 23 (CAS 509074-26-4)
- Ceftazidime Impurity 51 (CAS CATO-C4X-121251)
- Lornoxicam Impurity 15 (CAS CATO-C4X-201615)
- 1-(5,6-Dimethylpyrazin-2-yl)propan-1-one (CAS 86461-67-8)
- 3,3-Dimethyl-1-oxoisoindoline-5-carbonitrile (CAS 1440519-98-1)
- 5-(4-(1H-1,2,4-Triazol-1-yl)phenyl)-2H-tetrazole (CAS 1423810-54-1)
- N-(2-(Trifluoromethyl)thiazol-4-yl)acetamide (CAS 113732-72-2)
- 3,5-Difluoro-4-(1,4-oxazepan-4-yl)aniline (CAS 918137-45-8)
- (3-Bromophenyl)(heptyl)sulfane (CAS 1332355-01-7)
- Cholecystokinin, CCK Tetrapeptide (30-33) (CAS 35144-91-3)
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